Hutchison China MediTech’s Elunate, which recently became the first China-made drug to win a major oncology approval, has flopped in a key non-small cell lung cancer trial.
The Eli Lilly-partnered VEGFR inhibitor failed to beat out placebo at extending the lives of NSCLC patients in China who have failed two lines of chemotherapy. While it did increase the time to cancer progression and the response rate among patients, overall survival is widely considered the most important measure of an oncology drug's success.
“While the study demonstrates a significant reduction in disease progression in this challenging lung cancer patient population, we are disappointed that this benefit did not translate into an increase in overall survival,” Chi-Med chairman, Simon To, said in a statement.
The joy around Elunate at Chi-Med was short-lived. It was only two months ago that the drug made history as the first China-discovered medicine to be cleared for a major cancer type when China’s drug regulator green-lighted the product as a treatment for third-line colorectal cancer. Through a collaboration deal signed back in 2013, Lilly is now preparing for that launch in China.
Chi-Med is not giving up on the drug in lung cancer, though. The company has paired it with another TKI, AstraZeneca’s Iressa, in first-line NSCLC. And preliminary results from the phase 2 showed an overall response rate of 76%.
Also in China, the company is testing Elunate in combination with Bristol-Myers Squibb’s chemotherapy drug Taxol in a phase 3 in stomach cancer, one of the most common cancer types in Asian countries. An interim analysis from that trial is expected in the first half of 2019. Just last month, the company inked a pact with Walvax’s Genor Biopharma to combine Elunate with investigational PD-1 inhibitor genolimzumab.
Chi-Med’s ambitions for its first commercial product extend beyond China. The company started a phase 1 study last December testing Elunate in U.S. patients with advanced solid tumors. The study is about to finish, and proof-of-concept studies are planned for 2019, the company said.
“We remain confident that the high selectivity and lower off-target toxicities of [Elunate] are major points of differentiation,” To said. In the phase 3 colorectal cancer trial that earned it approval in China, Elunate demonstrated a better liver toxicity profile than what’s generally observed with other targeted therapies, Chi-Med CEO Christian Hogg has said. The company said low toxicity could open Elunate up to more combo possibilities.